Domestic ViolenceNCT02202824
Measuring Beliefs and Norms About Violence Against Women
A study testing Survey questionnaire in people with Domestic Violence, run by Massachusetts General Hospital at 1 site in Uganda.
Trial summary
The objective of our study was to determine the extent to which contextual information about the circumstances of intimate partner violence affects participants' responses to questions about their personal attitudes toward intimate partner violence. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence
- What is being tested?
- Survey questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,557 participants
- Where
- 1 siteUganda
- Study dates
- Jul 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older
- Emancipated minors aged 16-18 years
- Considers Nyakabare Parish their primary place of residence
- Capable of providing informed consent
Who cannot join
- Minors younger than 18 years, with the exception of emancipated minors
- Does not consider Nyakabare Parish their primary place of residence
- Unable to communicate with research staff, e.g., due to deafness, mutism, or aphasia
- Persons with psychosis, neurological damage, acute intoxication, or an intelligence quotient less than 70, as determined in the field by non-clinical research staff in consultation with a supervisor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring Beliefs and Norms About Violence Against Women in Rural Uganda: A Randomized Controlled Trial
The objective of our study was to determine the extent to which contextual information about the circumstances of intimate partner violence affects participants' responses to questions about their personal attitudes toward intimate partner violence.
Read the detailed description
In national studies conducted throughout sub-Saharan Africa, survey data indicate that there is widespread acceptance of intimate partner violence by both men and women (Alio et al., 2011, Mann \& Takyi, 2009, Rani et al., 2004, Uthman et al., 2009). For women, the proximate context of gender-unequal norms has important public health impacts. Men who report beliefs consistent with gender-unequal norms are more likely to be perpetrators of sexual violence (Shannon et al., 2012). Women are more likely to be victimized when they and their partners report concordant beliefs about the acceptability of intimate partner violence (Alio et al., 2011). And finally, women who live in areas characterized by gender-unequal norms about intimate partner violence are at greater risk for having their reproductive health compromised (Hung et al., 2012, Tsai \& Subramanian, 2012). Accurate measurement of norms about intimate partner violence therefore has important implications for understanding the health risk environment for women.
The Demographic and Health Surveys (DHS), which are nationally representative surveys conducted worldwide, have served as an important source of information on norms about intimate partner violence. However, a cross-country analysis of DHS data showed that minor deviations in survey wording may account for substantial cross-country variation in the extent to which women provide survey responses consistent with acceptance of intimate partner violence (Yount et al., 2011). Furthermore, in-depth interviews conducted among Bangladeshi women suggest that affirmative responses to DHS-style questions may better reflect their perceptions of prevailing norms or their individualized assumptions about contextual details rather than true beliefs about their acceptance of intimate partner violence (Schuler \& Islam, 2008, Schuler et al., 2011). Taken together, these lines of inquiry suggest important limitations in the accuracy with which the DHS measure women's attitudes towards intimate partner violence.
- Conditions
- Domestic Violence
- Being tested
- Survey questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey questionnaireOther
Each of the scale versions elicits personal attitudes toward intimate partner violence and perceived norms about intimate partner violence, in a different fashion
| Study group | Role | What they receive |
|---|---|---|
| Survey questionnaire version 1 | Experimental | Study participants will receive version 1 of the survey questionnaire Receives: Other: Survey questionnaire |
| Survey questionnaire version 2 | Experimental | Study participants will receive version 2 of the survey questionnaire Receives: Other: Survey questionnaire |
| Survey questionnaire version 3 | Experimental | Study participants will receive version 3 of the survey questionnaire Receives: Other: Survey questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal attitudes toward intimate partner violence (5-item scale)
Measured: Baseline
Perceived norms about intimate partner violence (5-item scale)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,557 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mbarara University of Science and Technology
- Responsible party
- Principal investigator, Alexander Tsai, Massachusetts General Hospital
- Investigators
- Alexander C Tsai, MD, PhD, Principal investigator, Massachusetts General HospitalBernard Kaukhikire, MBA, Principal investigator, Mbarara University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202824
- Sponsor's protocol ID
- MH096620-S1
- Status last verified
- Nov 2015
- First submitted
- 26 Jul 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tsai AC, Kakuhikire B, Perkins JM, Vorechovska D, McDonough AQ, Ogburn EL, Downey JM, Bangsberg DR. Measuring personal beliefs and perceived norms about intimate partner violence: Population-based survey experiment in rural Uganda. PLoS Med. 2017 May 23;14(5):e1002303. doi: 10.1371/journal.pmed.1002303. eCollection 2017 May.
PubMed 28542176
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Beliefs and Norms About Violence Against Women in Rural Uganda: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02202824
- Acronym / sponsor ID
- MH096620-S1
- Conditions
- Domestic Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,557 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Mbarara University of Science and Technology
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 29 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of our study was to determine the extent to which contextual information about the circumstances of intimate partner violence affects participants' responses to questions about their personal attitudes toward intimate partner violence.
Detailed description
In national studies conducted throughout sub-Saharan Africa, survey data indicate that there is widespread acceptance of intimate partner violence by both men and women (Alio et al., 2011, Mann \& Takyi, 2009, Rani et al., 2004, Uthman et al., 2009). For women, the proximate context of gender-unequal norms has important public health impacts. Men who report beliefs consistent with gender-unequal norms are more likely to be perpetrators of sexual violence (Shannon et al., 2012). Women are more likely to be victimized when they and their partners report concordant beliefs about the acceptability of intimate partner violence (Alio et al., 2011). And finally, women who live in areas characterized by gender-unequal norms about intimate partner violence are at greater risk for having their reproductive health compromised (Hung et al., 2012, Tsai \& Subramanian, 2012). Accurate measurement of norms about intimate partner violence therefore has important implications for understanding the health risk environment for women.
The Demographic and Health Surveys (DHS), which are nationally representative surveys conducted worldwide, have served as an important source of information on norms about intimate partner violence. However, a cross-country analysis of DHS data showed that minor deviations in survey wording may account for substantial cross-country variation in the extent to which women provide survey responses consistent with acceptance of intimate partner violence (Yount et al., 2011). Furthermore, in-depth interviews conducted among Bangladeshi women suggest that affirmative responses to DHS-style questions may better reflect their perceptions of prevailing norms or their individualized assumptions about contextual details rather than true beliefs about their acceptance of intimate partner violence (Schuler \& Islam, 2008, Schuler et al., 2011). Taken together, these lines of inquiry suggest important limitations in the accuracy with which the DHS measure women's attitudes towards intimate partner violence.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Survey questionnaire version 1 | Experimental | Other: Survey questionnaireStudy participants will receive version 1 of the survey questionnaire |
| Survey questionnaire version 2 | Experimental | Other: Survey questionnaireStudy participants will receive version 2 of the survey questionnaire |
| Survey questionnaire version 3 | Experimental | Other: Survey questionnaireStudy participants will receive version 3 of the survey questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years and older
- Emancipated minors aged 16-18 years
- Considers Nyakabare Parish their primary place of residence
- Capable of providing informed consent
Key exclusion criteria (4 listed)
- Minors younger than 18 years, with the exception of emancipated minors
- Does not consider Nyakabare Parish their primary place of residence
- Unable to communicate with research staff, e.g., due to deafness, mutism, or aphasia
- Persons with psychosis, neurological damage, acute intoxication, or an intelligence quotient less than 70, as determined in the field by non-clinical research staff in consultation with a supervisor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey questionnaireEach of the scale versions elicits personal attitudes toward intimate partner violence and perceived norms about intimate partner violence, in a different fashion | Other | Survey questionnaire version 1, Survey questionnaire version 2, Survey questionnaire version 3 |
Primary outcome
Personal attitudes toward intimate partner violence (5-item scale)
Time frame: Baseline
Perceived norms about intimate partner violence (5-item scale)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Derived from this study: PubMed 28542176Tsai AC, Kakuhikire B, Perkins JM, Vorechovska D, McDonough AQ, Ogburn EL, Downey JM, Bangsberg DR. Measuring personal beliefs and perceived norms about intimate partner violence: Population-based survey experiment in rural Uganda. PLoS Med. 2017 May 23;14(5):e1002303. doi: 10.1371/journal.pmed.1002303. eCollection 2017 May.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander C Tsai, MD, PhD principal investigator
Massachusetts General Hospital
Bernard Kaukhikire, MBA principal investigator
Mbarara University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey questionnaire in people with Domestic Violence, run by Massachusetts General Hospital at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal attitudes toward intimate partner violence (5-item scale) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02202824, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.